Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Not applicable

Invasive Versus Non-invasive Approach in Symptomatic Patient With Non-High Risk Coronary Artery Stenosis

NCT05799092 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2023-10-02
Last updated
2025-11-20

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Invasive coronary angiographyNon-invasive functional test

Invasive coronary angiography: As alternative to non-invasive functional testing, invasive coronary angiography will be performed.

Non-invasive functional test: Standard non-invasive functional testing will be performed.

Study summary

A pragmatic, prospective, multi-center, open label, randomized controlled, superiority trial.

The study will compare clinical outcomes between invasive versus non-invasive approach as next diagnostic step in symptomatic patients with non-high risk obstructive coronary artery disease (CAD) on coronary computed tomography-angiography (CCTA).

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Subject age ≥19 years old 2. Patients with new or worsening chest pain syndrome, equivalent symptoms, or abnormal laboratory test findings (suspected ischemic changes in electrocardiography, regional wall motion abnormality in echocardiography, or coronary calcium score \> 100) suspected for clinically significant CAD who are evaluated by CCTA 3. Any other clinical circumstance in which physician judged to proceed CCTA 4. Obstructive CAD in CCTA (≥50% diameter stenosis) 5. Subject who can verbally confirm understandings of risks, benefits, and treatment alternatives of receiving invasive approach and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. Exclusion Criteria: 1. Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing (elevated cardiac troponin or CK-MB) 2. High risk CAD (left main stenosis ≥ 50%; anatomically significant 3-vessel disease with ≥70% stenosis) 3. Hemodynamically or clinically unstable condition (systolic BP \< 90 mmHg, ventricular arrhythmias, or persistent resting chest pain in ischemic nature despite adequate therapy 4. Known CAD with previous MI, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) 5. Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock) 6. Known significant congenital, severe valvular or cardiomyopathic (hypertrophic or dilated cardiomyopathy, or any other forms) process which could explain cardiac symptoms. 7. Severe left ventricular systolic dysfunction (ejection fraction \<30%) 8. Intolerance to Aspirin, Clopidogrel, or Heparin. 9. Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment) 10. Unwillingness or inability to comply with the procedures described in this protocol.

Primary outcome measure(s)

  • Time to first event of major adverse cardiac events (MACE) — 2 years after the last patient enrollment
    MACE is a composite of death from any causes, myocardial infarction (MI), clinically driven unplanned revascularization.

Trial sites (22)

FacilityCityRegionStatus
SoonChunHyang University Hospital Bucheon Bucheon-si South Korea Recruiting
Kangwon National University Hospital Chuncheon South Korea Recruiting
Chungbuk National University Hospital Chungju South Korea Recruiting
Keimyung University Dongsan Medical Center Daegu South Korea Recruiting
Kyungpook National University Hospital Daegu South Korea Recruiting
Chungnam National University Hospital Daejeon South Korea Recruiting
Chonnam National University Gwangju South Korea Recruiting
Chung-Ang University Gwangmyeong Hospital Gwangmyeong South Korea Recruiting
Inje university Ilsan Paik hospital Ilsan South Korea Recruiting
Gachon University Gil Medical Center Incheon South Korea Recruiting
Kwandong University Intl. ST. Mary's Hospital Incheon South Korea Recruiting
Gyeongsang National University Hospital Jinju South Korea Recruiting
Seoul National University Bundang Hospital Seongnam-si South Korea Recruiting
Chung-Ang University Hospital Seoul South Korea Recruiting
Ewha Womans University Mokdong Hospital Seoul South Korea Recruiting
Ewha Womans University Seoul Hospital Seoul South Korea Recruiting
Hanyang University Seoul Hospital, College of Medicine, Hanyang University Seoul South Korea Recruiting
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine Seoul South Korea Recruiting
Korea University Anam Hospital Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Seoul National University Boramae Medical Center Seoul South Korea Recruiting
Ajou University Hospital Suwon South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05799092 on ClinicalTrials.gov ↗ ← All trials in South Korea